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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICULAR CATHETER, STANDARD, BARIUM IMPREGNATED, 23 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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MEDTRONIC NEUROSURGERY VENTRICULAR CATHETER, STANDARD, BARIUM IMPREGNATED, 23 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 41101
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/30/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the device was explanted as part of a shunt removal.
 
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Brand Name
VENTRICULAR CATHETER, STANDARD, BARIUM IMPREGNATED, 23 CM
Common Device Name
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
MDR Report Key8348223
Report Number2021898-2019-00062
Device Sequence Number2105816
Product Code JXG
UDI-Device Identifier00643169466500
UDI-Public00643169466500
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K792007
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date10/31/2022
Device Model Number41101
Device Catalogue Number41101
Device Lot NumberE39690
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/30/2019
Initial Report FDA Received Date02/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age30 YR
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